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Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer

NCT00462735 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-03-13

Study results available
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Summary

For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.

Conditions

  • Head and Neck Cancer
  • Cancer of the Pharynx
  • Cancer of the Larynx
  • Nose Neoplasms
  • Paranasal Sinus Neoplasms
  • Cancer of the Oral Cavity

Interventions

DRUG

Cetuximab

250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients

DRUG

Hydroxyurea

500 mg orally every 12 hours with the morning dose administered 2 hours before radiation

DRUG

Fluorouracil

continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours

PROCEDURE

radiotherapy

Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule. Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.

Sponsors & Collaborators

  • Johnny Kao

    lead OTHER

Principal Investigators

  • Johnny Kao, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00462735 on ClinicalTrials.gov